BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP

    MDR report key: 10482087 · Received September 2, 2020

    Report

    Report Number
    0001032347-2020-00408
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    August 12, 2020
    Report Date
    November 6, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036013189
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONSIDERED TO BE CONFIRMED BECAUSE IT WAS REPORTED THAT ADDITIONAL IMAGING AND A CONSULTATION WERE CONDUCTED. THE TW DRILL 1.1X50MM 9MMSTOP W/NT (ITEM# 01-7146, LOT# 834540) WAS NOT RETURNED FOR INVESTIGATION AND NO PHOTOS, SCANS, X-RAYS, OR PHYSICIAN'S REPORTS WERE PROVIDED. FOR THESE REASONS, NO FUNCTIONAL TESTING OR VISUAL EVALUATION COULD BE CONDUCTED. THE CERT WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT FOR THIS ITEM# 01-7146, VENDOR LOT# 834540. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS EXCESSIVE FORCE WAS APPLIED, BEYOND WHAT THE DRILL WAS DESIGNED TO ENCOUNTER. IT IS POSSIBLE THAT THE DRILL WAS USED OVER ITS MAXIMUM RECOMMENDED SPEED, IT WAS USED TO DRILL INTO HIGH DENSITY BONE, EXCESSIVE NORMAL FORCE WAS APPLIED DURING DRILLING, OR OFF-AXIS FORCES WERE APPLIED DURING DRILLING. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING FIELDS WERE UPDATED: DATE OF THIS REPORT. DESCRIBE EVENT OR PROBLEM. RELEVANT TESTS/LABORATORY DATA. DATE RECEIVED BY MANUFACTURER. TYPE OF REPORT. FOLLOW UP TYPE. ADDITIONAL NARRATIVES/DATA.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DRILL FRACTURED AND RESULTED IN THE RETENTION OF A FOREIGN BODY DURING A PROCEDURE ON A LEFT ORBITAL FRACTURE. THE SURGEON PLACED ORBITAL MESH AND WAS AFFIXING A SUTURE TO THE FRACTURED BONE WHEN THE DRILL FRACTURED. A FLUOROSCOPY WAS PERFORMED AND AN X-RAY IMAGED A MILLIMETRIC FOREIGN BODY INSIDE THE BONE. FOLLOWING AN ENT CONSULTATION, IT WAS DETERMINED THAT THE RETAINED FOREIGN BODY DID NOT POSE A THREAT TO THE PATIENT¿S HEALTH. THE MILLIMETRIC FRACTURED TIP OF THE DRILL WAS NOT REMOVED FROM THE MAXILLA BONE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. OCCUPATION: PURCHASING ASSISTANT SPECIALIST. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE ¿ (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL FRACTURED AND RESULTED IN THE RETENTION OF A FOREIGN BODY DURING A PROCEDURE ON A LEFT ORBITAL FRACTURE. THE SURGEON PLACED ORBITAL MESH AND WAS AFFIXING A SUTURE TO THE FRACTURED BONE WHEN THE DRILL FRACTURED. THE PIECE OF THE FRACTURED DRILL COULD NOT BE REMOVED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949676 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A 834540 00841036013189

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R